01 1ACCORD HLTHCARE
02 1ACTAVIS INC
03 1AM REGENT
04 2AMNEAL
05 2AMNEAL PHARMS CO
06 2BAXTER HLTHCARE CORP
07 2BIOXCEL
08 3ENDO OPERATIONS
09 3EUGIA PHARMA
10 5FRESENIUS KABI USA
11 1GLAND
12 2GLAND PHARMA LTD
13 4HENGRUI PHARMA
14 3HIKMA
15 5HOSPIRA
16 4HQ SPCLT PHARMA
17 1MEITHEAL
18 2MILLA PHARMS
19 1MYLAN INSTITUTIONAL
20 2MYLAN LABS LTD
21 1PIRAMAL CRITICAL
22 1RISING
23 1SANDOZ
24 2SOMERSET
25 3TAGI
26 1TEVA PHARMS USA
27 3WILSHIRE PHARMS INC
28 1ZYDUS PHARMS
01 2FILM;BUCCAL, SUBLINGUAL
02 52INJECTABLE;INJECTION
03 6SOLUTION;INTRAVENOUS
01 3DISCN
02 56RX
03 1Blank
01 53DEXMEDETOMIDINE HYDROCHLORIDE
02 2IGALMI
03 5PRECEDEX
01 48No
02 11Yes
03 1Blank
RLD : No
TE Code : AP
Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date : 2015-09-18
Application Number : 201072
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date : 2015-08-20
Application Number : 202126
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : PRECEDEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date : 1999-12-17
Application Number : 21038
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : PRECEDEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date : 2013-03-13
Application Number : 21038
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : PRECEDEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Approval Date : 2013-03-13
Application Number : 21038
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : PRECEDEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)
Approval Date : 2014-11-14
Application Number : 21038
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code :
Brand Name : PRECEDEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)
Approval Date : 2020-01-31
Application Number : 21038
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code : AP
Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date : 2014-11-24
Application Number : 202585
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date : 2016-06-14
Application Number : 91465
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date : 2014-08-18
Application Number : 202881
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
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